Prosthetic incision device and methods thereof

ABSTRACT

A modular surgical apparatus is disclosed. Also disclosed is a modular incision apparatus. The modular incision apparatus may be used in a minimally invasive surgery. The modular incision apparatus includes a base having a pair of pivots, a pair of alignment tabs, a proximal opening, and at least one slide guide. The modular incision apparatus includes visual and cleaning access to the blade. The modular incision apparatus is suitable for safely, efficiently, and accurately making small incisions during surgical procedures. The modular incision apparatus provides a means of making small incisions of controlled depth, while reducing the chances of inadvertent exposure of surgical staff to sharp instrument.

RELATED APPLICATIONS

This patent application is a continuation in part of 35 U.S.C. 371National Stage application Ser. No. 15/735,816, filed Dec. 12, 2017,entitled “PROSTHETIC SUTURING DEVICE AND METHODS THEREOF”. applicationSer. No. 15/735,816 is a National Stage Application of PCT ApplicationPCT/US2017/057057, filed Oct. 17, 2017, which claims priority to U.S.Provisional Patent Application No. 62/409,304 filed Oct. 17, 2016 and isentitled “PROSTHETIC SUTURING DEVICE AND METHODS THEREOF”. This patentapplication also claims priority to U.S. Provisional Patent ApplicationNo. 62/622,914 filed Jan. 28, 2018 and is entitled “MODULAR INCISIONAPPARATUS.” The entire 62/409,304, PCT/US2017/057057, 15/735,816, and62/622,914 applications are hereby incorporated by reference in theirentirety.

FIELD

The claimed invention relates to surgical suturing devices, and morespecifically to surgical suturing devices suitable for use withprosthetic devices, especially cardiac prosthetic devices such asreplacement heart valves. The claimed invention also relates to surgicaldevices of a modular nature, including a modular incision apparatus.

BACKGROUND

Modern advances in cardiac surgery have made it possible to replaceheart valves using minimally invasive surgical techniques. As minimallyinvasive techniques have improved, surgeons are able to operate onpatients through smaller and smaller access holes, resulting in lessperioperative pain and shorter recovery times. A main focus ofinnovations in minimally invasive cardiac surgery has been on the toolswhich pass into the patient, through the small access holes, to placesuture stitches more efficiently and reliably. By focusing onimprovements to these steps of the surgical procedures, patients areable to be on cardio-pulmonary bypass machines for shorter times,thereby improving patient outcomes. Resultant efficiency improvementswhile working within the patient further help to reduce stress andfatigue on surgeons.

It would also be advantageous to focus on efficiency outside of thepatient. Surgical teams are regularly working to streamline their ownprocesses to enable surgeons to be as efficient as possible. In manyminimally invasive surgical procedures, the ends of sutures which havebeen stitched within a patient are brought back out of the patientthrough one of the access sites so that the suture ends can be keptorganized and then stitched through a sewing ring of a prostheticdevice. Unfortunately, the suture ends often have adapters which werepreviously used to enable a corresponding minimally invasive suturingdevice to manipulate the suture ends within the patient. While it mightbe possible to reload the adapters (and therefore the suture ends) intothe minimally invasive suturing device, such devices (meant forin-patient use and suturing tissue) are often not compatible withsuturing a sewing cuff of a prosthetic device. As a result, surgicalteams are forced to cut off the adapters and thread each suture onto aneedle in order to manually stitch each suture end through a prostheticvalve's sewing cuff. For many cardiac surgical procedures,unfortunately, this can increase the overall time a patient is oncardio-pulmonary bypass (CPB). Longer CPB times are associated withcomplications of the inflammatory system, heart, lungs, kidneys, andbrain. Therefore, it would be desirable to have a prosthetic suturingdevice that is compatible with one or more suture adapters which havebeen used with a minimally invasive surgical suturing device and whichhas features to increase the efficiency of a surgical team and reduceCPB time.

The human heart relies on a series of one-way valves to help control theflow of blood through the chambers of the heart. For example, referringto FIG. 1A, deoxygenated blood returns to the heart 20, via the superiorvena cava 22 and the inferior vena cava 24, entering the right atrium26. The heart muscle tissue contracts in a rhythmic, coordinatedheartbeat, first with an atrial contraction which aids blood in theright atrium 26 to pass through the tricuspid valve 28 and into theright ventricle 30. Following atrial contraction, ventricularcontraction occurs and the tricuspid valve 28 closes. Ventricularcontraction is stronger than atrial contraction, assisting blood flowthrough the pulmonic valve 32, out of the heart 20 via the pulmonaryartery 34, and to the lungs (not shown) for oxygenation. Following theventricular contraction, the pulmonic valve 32 closes, preventing thebackwards flow of blood from the pulmonary artery 34 into the heart 20.

Oxygenated blood returns to the heart 20, via the pulmonary veins 36,entering the left atrium 38. Left atrial contraction assists blood inthe left atrium 38 to pass through the mitral valve 40 and into the leftventricle 42. Following the atrial contraction, ensuing ventricularcontraction causes mitral valve 40 closure, and pushes oxygenated bloodfrom the left ventricle 42 through the aortic valve 44 and into theaorta 46 where it then circulates throughout the body. Following leftventricular contraction, the aortic valve 44 closes, preventing thebackwards flow of blood from the aorta 46 into the heart 20.

Unfortunately, one or more of a person's heart valves 28, 32, 40, and 44can have or develop problems which adversely affect their function and,consequently, negatively impact the person's health. Generally, problemswith heart valves can be organized into two categories: regurgitationand/or stenosis. Regurgitation occurs if a heart valve does not sealtightly, thereby allowing blood to flow back into a chamber rather thanadvancing through and out of the heart. This can cause the heart to workharder to remain an effective pump. Regurgitation is frequently observedwhen the mitral valve 40 prolapses (extends back) into the left atrium38 during a ventricular contraction. Stenosis, by contrast, is when aheart valve does not fully patent due to stiff or fused leaflets, bloodflow tract narrowing, or obstructive material buildup (e.g., calcium).The resultant narrowed outflow causes the heart to work harder to pumpblood through it, possibly leading to heart failure.

Fortunately, advances in cardiac surgery, and in particular theevolution of reliable cardio-pulmonary bypass (CPB), have enabled openheart and less-invasive methods for heart valve replacement. During CPB,deoxygenated blood is diverted from the superior vena cava 22 andinferior vena cava 24 in or near the right atrium 26 of the heart 20,brought outside the body to a CPB machine, reoxygenated, and returned tothe body at the aorta 46, or other great arterial vessels, therebybypassing the heart 20 and making it possible to stop the heart 20 forcardiac surgery.

Unfortunately, while such cardiac procedures have become common-place,they are not without risks. In particular, extended time on a CPBmachine can increase a patient's chances of developing complicationsinvolving the inflammatory system, heart, lungs, kidneys, brain, etc. Aninflammatory response can be triggered by blood coming into contact withthe foreign substances of the tubing leading to the CPB machine and thecomponents of the machine itself. These types of inflammatory responsescan damage the endothelium (inner layer of cells) of blood vessels,making them more susceptible to platelet and clot adhesion, andultimately to an increased chance of atherosclerosis and othercardiovascular complications. Additionally, aortic clamping, necessaryto establish the CPB, may cause inadequate blood flow to certain organs,for example, the heart, lungs, kidneys, or brain, thereby leading topossible ischemic damage to those organs. The risks of complications dueto CPB increase dramatically with the amount of time a patient isactively connected to the CPB machine. Accordingly, surgeons rely on acombination of specialized skills, knowledge, technologies, and teamworkto operate as efficiently as possible in order to minimize a patient'stime on CPB.

Depending on the number of valves being replaced for a patient, atypical heart valve replacement surgery can last between two to sixhours, one to two hours of which can be spent on a CPB machine. Whilethe patient is on CPB, the surgeon must gain access to the heart valve,remove the pathologic valve tissue as necessary, and install areplacement valve at the location of the original valve. The valveinstallation process, typically requiring suture placement andfastening, can be very time consuming, especially when surgeons areoperating through small access sites when employing less-invasivetechniques to reduce surgical trauma. Furthermore, a large number ofsutures and their loose ends must be effectively managed to track whichsuture ends go together and ensure the sutures do not get tangled. As anexample, FIG. 1B schematically illustrates a surgical situation during aminimally invasive aortic valve replacement. The defective valve tissuehas been removed and multiple sutures 48 have been placed into thetissue of the aortic root. These sutures 48 must be managed and sewnthrough a sewing cuff of a replacement valve 50 before the valve 50 isslid down the suture lines and into the aortic root where the sutureends will be secured to anchor the heart valve 50. The suture managementand the sewing into the cuff can be very time consuming. Therefore,there is a need for devices and methods which enable surgeons to operatemore efficiently during surgery to replace pathologic anatomicalstructures, such as, but not limited to, replacement heart valves. Suchdevices and methods can reduce the amount of time patients need to beattached to a CPB machine, thereby reducing the likelihood ofCPB-related side effects. Faster cardiac operations offer additionalbenefits, such as reduced surgical team fatigue and more efficient useof critical resources. Expediting cardiac surgery can also improvepatient outcomes.

Other areas of minimally invasive surgeries could also benefit from afocus on efficiency and safety. For example, in order to facilitateminimally invasive surgeries, it is often beneficial for one or moresmall (5-10 mm diameter) cannulas to be placed in the patient's chestthrough a small incision. Surgeons typically use a scalpel to make suchincisions. It is important for such incisions to be of a controlleddepth so that internal organs and major vessels are not cutinadvertently. It is also very important for the surgeon and thesurgical staff to be careful when handling and passing the scalpel backand forth to each other. If the blade on the scalpel nicks or otherwisecuts anyone on the surgical team, the person in question is put at riskfor possibly contracting any of a number of serious diseases from thepatient's blood, including hepatitis or HIV. Therefore, it would bedesirable to have a modular incision apparatus which is compatible withexisting minimally invasive tools which can be used to reliably createsmall incisions while reducing the opportunity for surgical staff to beexposed to sharp instruments.

SUMMARY

A modular surgical apparatus is disclosed. The modular surgicalapparatus comprises a modular incision apparatus. The modular incisionapparatus includes a base having a pair of pivots, a pair of alignmenttabs, a proximal opening, and at least one slide guide. The modularincision apparatus also includes a cover coupled to the base, the coverhaving at least one retention latch. The modular incision apparatus alsoincludes a blade having at least one slide for movement within the atleast one slide guide, a cutting edge on a distal end. The modularincision apparatus may also include a coupling connector on a proximalend which is accessible via the proximal opening of the base. Themodular incision apparatus may also include a release slot, or aflexible latch held by one or more of the base and cover.

The modular incision apparatus further includes an access notch toprovide visual and cleaning access to the blade, where at least one of acover and a base includes a transparent material. The modular incisionapparatus may also include a coupling connector with a substantiallycircular shape, and where the base, the cover, or both define a distalopening from which a cutting edge may exit.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a sectional view of a heart.

FIG. 1B schematically illustrates a surgical situation during aminimally invasive aortic valve replacement.

FIG. 2A is a perspective view of one embodiment of a prosthetic suturingdevice.

FIG. 2B is a partially exposed perspective view of the prostheticsuturing device of FIG. 1A with a portion of the housing removed.

FIG. 3 is an exploded perspective view of the prosthetic suturing deviceof FIG. 2B.

FIG. 4A is an enlarged perspective view of one embodiment of a needleguide tube for a prosthetic suturing device.

FIGS. 4B, 4C, and 4D are side, back, and front elevational views,respectively, of the needle guide tube of FIG. 4A.

FIG. 5 is an enlarged perspective view of one embodiment of a guide tipfor a prosthetic suturing device shown from a distal perspective.

FIG. 6 is an enlarged perspective view of the guide tip from FIG. 5shown from a proximal perspective.

FIG. 7B is a partially cross-sectioned side view of the prostheticsuturing device of FIG. 2B with the needles in a retracted position.

FIG. 7A is a top view of the device from FIG. 7B, hiding the handle,housing, spring, and hard stop in order to more clearly show theproximal needle orientation.

FIG. 8B is a partially cross-sectioned side view of the prostheticsuturing device of FIG. 2B, with the needles in a partially engagedposition as they pass through the cuff-receiving area.

FIG. 8A is a top view of the device from FIG. 8B, hiding the handle,housing, spring, and hard stop in order to more clearly shown theproximal needle orientation.

FIG. 9B is a partially cross-sectioned side view of the prostheticsuturing device of FIG. 2B, with the needles in a fully engaged positionand coupled to the suture ferrules held in the distal end of the guidetip.

FIG. 9A is a top view of the device from FIG. 9B, hiding the handle,housing, spring, and hard stop in order to more clearly show theproximal needle orientation.

FIG. 10B is a partially cross-sectioned side view of the prostheticsuturing device of FIG. 2B, with the needles partially retracted andpulling the suture ferrules and suture back through the cuff receivingarea.

FIG. 10A is a top view of the device from FIG. 10B, hiding the handle,housing, spring, and hard stop in order to more clearly show theproximal needle orientation.

FIG. 11B is a partially cross-sectioned side view of the prostheticsuturing device of FIG. 2B, with the needles fully retracted.

FIG. 11A is a top view of the device from FIG. 11B, hiding the handle,housing, spring, and hard stop in order to more clearly show theproximal needle orientation.

FIG. 11C is an enlarged partial cross-sectional view of the guide tipfrom FIG. 11B, showing the ferrules coupled to the needles being helddistally to the ferrule removal spring.

FIG. 12B is a partially cross-sectioned side view of the prostheticsuturing device of FIG. 2B, with the needles hyper-retracted.

FIG. 12A is a top view of the device from FIG. 12B, hiding the handle,housing, spring, and hard stop in order to more clearly show theproximal needle orientation.

FIG. 12C is an enlarged partial cross-sectional view of the guide tipfrom FIG. 12B, showing the ferrules decoupled from the needles afterhaving been removed from the needles by the ferrule removal spring.

FIG. 13 is an exploded perspective view of another embodiment of aprosthetic suturing device.

FIG. 14 is a partially exposed side view of the prosthetic suturingdevice of FIG. 13.

FIG. 15 is a perspective view of one embodiment of a guide tip for aprosthetic suturing device.

FIG. 16 is a partially exposed partial cross-sectional perspective viewof another embodiment of a prosthetic suturing device, utilizing theguide tip of FIG. 15 without a needle guide tube.

FIG. 17 is a partially exposed side view of a further embodiment of aprosthetic suturing device.

FIG. 18 is a partially exposed side view of another embodiment of aprosthetic suturing device.

FIGS. 19A-19F illustrate one example of a surgical usage of anembodiment of a prosthetic suturing device.

FIGS. 20A-20B are perspective views of one embodiment of a surgicalsuturing device and one embodiment of a magazine for the surgicalsuturing device.

FIG. 21 is an exploded view of the surgical suturing device of FIG. 20A.

FIG. 22 is an exploded view of the suturing magazine of FIG. 20A.

FIGS. 23A-23F show top, front, left, right, bottom, and rear(upside-down) elevational views, respectively, of the magazine of FIG.22.

FIG. 24 shows an embodiment of the magazine inserted into the magazinereceiver of the suturing device.

FIGS. 25A and 25B are exposed top and side views, respectively, of thesurgical suturing device tip of the device from FIG. 20A.

FIGS. 26A-26E are partial cross-sectional side views of the surgicalsuturing device and magazine of FIG. 20A being used to place a suturestitch in a sewing cuff of a replacement heart valve.

FIGS. 27A-27G are perspective views of the surgical suturing device andmagazine of FIG. 20A being used to place a suture stitch in a sewingcuff of a replacement heart valve.

FIGS. 28A-28G schematically illustrate one embodiment of how the indexerportion of the suturing device and the indexable feature of the magazinework together to index or move the magazine from one position toanother.

FIG. 29 is a side view of another embodiment of a magazine for asuturing device.

FIGS. 30A-33B schematically illustrate side views of different suturemagazine receivers and corresponding magazines for use in a suturingdevice.

FIG. 34A illustrates one embodiment of a surgical suturing device havinga cassette receiver.

FIG. 34B is the surgical suturing device of FIG. 34A in a partiallyexposed view.

FIG. 35 is an exploded view of the surgical suturing device of FIG. 34A.

FIG. 36 is an enlarged view of the needle drivers in an exposed view ofa portion of the surgical suturing device of FIG. 34A.

FIG. 37 is an enlarged view of the needle receivers and the cassettereceiver of the surgical suturing device of FIG. 34A.

FIGS. 38A and 38B are different perspective views of a cassetteembodiment for use with the surgical suturing device of FIG. 34A.

FIG. 39 is an exploded view of the cassette of FIG. 38A.

FIGS. 40A, 40B, 40C, 40D, 40E, and 40F are top, front, left, right,back, and bottom views of the cassette of FIG. 38A.

FIG. 41A is a perspective view of a surgical situation where a suturehas been stitched into a tissue and ferrules on the ends of the sutureare ready to be placed into the cassette of FIG. 38A.

FIG. 41B illustrates the ferrules of FIG. 41A having been installed intothe cassette of FIG. 38A.

FIG. 41B-1 is an enlarged view of the distal end of the cassette fromFIG. 41B showing the ferrules installed in the cassette.

FIG. 42 illustrates multiple cassettes in a surgical situation whereeach cassette is coupled to ferrules on the ends of a different suturethat has been stitched into a patient. The suture ends leading to eachcassette are being held by a suture organizer.

FIG. 43 shows a partially exposed view of the back side of the cassetteof FIG. 38A to illustrate the connector ends of the needles in thecassette and how they are configured to mate with the needle drivers ofthe surgical suturing device.

FIG. 44A illustrates the cassette of FIG. 38A ready to be loaded intothe cassette receiver of the suturing device of FIG. 34.

FIG. 44B shows pivots of the cassette of FIG. 38A placed into alignmentwith pivot receivers in the cassette receiver.

FIG. 44B-1 is an enlarged view of the cassette and cassette receiver ofFIG. 44B.

FIG. 44C shows the cassette having been rotated down around the cassettepivots so that the connector ends of the needles are coupled to theneedle drivers of the suturing device.

FIG. 45 is a cross-sectional view of the cassette installed in thecassette receiver of the suturing device.

FIGS. 46A-46G illustrate how the surgical suturing device, with itsinstalled cassette, may be used to place a suture stitch in a sewingcuff of a replacement heart valve.

FIG. 47 illustrates a surgical situation where several pairs of sutureends have been stitched through a sewing cuff of a replacement heartvalve. The cassettes still hold the ferrules on the suture ends, and theneedles remain out of reach in each cassette.

FIG. 48 illustrates one embodiment of a magazine having multiplecassettes.

FIG. 49A illustrates another embodiment of a surgical suturing devicehaving a cassette receiver.

FIG. 49B is the surgical suturing device of FIG. 49A in a partiallyexposed view.

FIG. 50 is an exploded view of the surgical suturing device of FIG. 49A.

FIG. 51 is an enlarged view of the needle drivers in an exposed view ofa portion of the surgical suturing device of FIG. 49A.

FIG. 52 is an enlarged view of the needle receivers and the cassettereceiver of the surgical suturing device of FIG. 49A.

FIGS. 53A and 53B are different perspective views of another cassetteembodiment for use with the surgical suturing device of FIG. 49A.

FIG. 54 is an exploded view of the cassette of FIG. 53A.

FIGS. 55A, 55B, 55C, 55D, 55E, and 55F are top, front, left, right,back, and bottom views of the cassette of FIG. 53A.

FIG. 56A is a perspective view of a surgical situation where a suturehas been stitched into a tissue and ferrules on the ends of the sutureare ready to be placed into the cassette of FIG. 53A.

FIG. 56B illustrates the ferrules of FIG. 56A having been installed intothe cassette of FIG. 53A.

FIG. 57 is an enlarged view of the distal end of the cassette from FIG.56B showing the ferrules installed in the cassette.

FIGS. 58A-58E illustrate how a suturing device for placing stitches intissue may be coupled to the cassette in order to facilitate loading ofthe ferrules into the cassette.

FIG. 58F shows a partially exposed view of the back side of the cassetteof FIG. 53A to illustrate the connector ends of the needles in thecassette and how they are configured to mate with the needle drivers ofthe surgical suturing device of FIG. 52.

FIG. 59A is a top perspective view of one embodiment of a modularincision apparatus.

FIG. 59B is a bottom perspective view of the modular incision apparatusof FIG. 1A.

FIGS. 60A, 60B, 60C, 60D, 60E, and 60F are front, left, right, rear,top, and bottom elevational views, respectively, of the modular incisionapparatus of FIG. 59A.

FIG. 61 is an exploded view of the modular incision apparatus of FIG.59A.

FIG. 62 illustrates one embodiment of an automated suturing device.

FIG. 63 is a partially exposed perspective view of the modular incisionapparatus of FIG. 1A illustrating the features which will couple withthe automated suturing device of FIG. 62.

FIGS. 64A and 64B are side cross-sectional views of the modular incisionapparatus of FIG. 59A showing the cutting blade in a retracted positionand in an extended position, respectively.

FIG. 65A is a top perspective view of another embodiment of a modularincision apparatus.

FIG. 65B is a bottom perspective view of the modular incision apparatusof FIG. 65A.

FIGS. 66A and 66B are side cross-sectional views of the modular incisionapparatus of FIG. 65A showing the cutting blade in a retracted positionand in an extended position, respectively.

It will be appreciated that for purposes of clarity and where deemedappropriate, reference numerals have been repeated in the figures toindicate corresponding features, and that the various elements in thedrawings have not necessarily been drawn to scale in order to bettershow the features.

DETAILED DESCRIPTION

FIG. 2A is a perspective view of one embodiment of a prosthetic suturingdevice 150. FIG. 2B is a partially exposed perspective view of theprosthetic suturing device 150 of FIG. 2A with a portion of the housing158 removed. The prosthetic suturing device 150 has a guide tip 152 thatdefines a cuff receiving area 154. The cuff receiving area 154 isconfigured to receive a portion of a sewing cuff of a replacementanatomical structure. Examples of a replacement anatomical structure mayinclude, but are not limited to, synthetic replacement heart valves andnatural tissue replacement heart valves. The sewing cuff on such areplacement anatomical structure is designed to be sewn with sutureagainst one or more tissue sites inside a patient so that thereplacement anatomical structure is held in a desired location. Itshould be understood that the term “suture”, as used herein, is intendedto cover any thread, cable, wire, filament, strand, line, yarn, gut, orsimilar structure, whether natural and/or synthetic, in monofilament,composite filament, or multifilament form (whether braided, woven,twisted, or otherwise held together), as well as equivalents,substitutions, combinations, and pluralities thereof for such materialsand structures. Furthermore, for convenience, this specification willoften utilize the example of a sewing cuff on a replacement heart valve,however, it should be understood that other types of replacementanatomical structures are contemplated as well. Such replacementanatomical structures having sewing cuffs are known to those skilled inthe art.

The guide tip 152 is coupled to a shaft 156 at a distal end 156D of theshaft 156. The prosthetic suturing device also has a housing 158 towhich a handle 160 is pivotably coupled at pivot point 162. The handle160 is biased by spring 164 towards a handle stop 166 which is formedfrom part of the housing 158. A hard stop 167 is also located in thehousing 158, in order to limit the travel of the handle 160 whensqueezed in a direction 174.

Shaft holders 168 couple a proximal end 156P of the shaft 156 to thehousing 158. First and second needles 170, 172 are in horizontalalignment where they are coupled to the handle 160 within the housing158. In this embodiment, the needles 170, 172 are routed by a needleguide tube (not visible in this view) so as to be in vertical alignmentnear the cuff-receiving area 154. Movement 174 of the portion of thehandle 160 outside of the housing 158 towards the grip 175 of thehousing 158 will move the needles 170, 172 across the cuff receivingarea 154. Since the grip 175 is part of the housing 158, portions ofthis specification may indicate that certain components are coupled tothe grip 175, which is accurate because the grip is part of the housing.

FIG. 3 is an exploded perspective view of the prosthetic suturing deviceof FIG. 2B. The distal ends 170E, 172E of the first and second needles170, 172 are each configured to engage a suture adapter (not shown here,but will be discussed later). A needle guide tube 176 having first andsecond spiral tracks 178, 180 is inserted into the proximal end 156P ofthe shaft 156, and shaft holders 168 are placed over the distal end 156Dof the shaft 156 and coupled to the proximal end 156P of the shaft. Thedistal end 156D of the shaft 156 is coupled to the guide tip 152. Adistal end 176D of the needle guide tube 176 abuts or lies close to aproximal portion 152P of the guide tip 152 inside a distal end 156D ofthe shaft 156. Starting with the needle ends 170E, 172E, the first andsecond needles 170, 172 are inserted into the first and second spiraltracks 178, 180 of the needle guide tube 176 as will be discussed below.The spiral tracks 178, 180 take the needles 170, 172 from a horizontalorientation to a vertical orientation at the proximal end of the device.

In the vertical orientation of the needles at the proximal end of thedevice, the second needle 172 will be located below the first needle170. Before the first needle 170 is fully inserted, a ferrule releasespring 182 may be inserted into a slot on the top of the guide tip 152so that it rests against the second needle 172. Then, the first needle170 can be fully inserted, compressing the ferrule release spring 182between the two needles 170, 172.

A first ball end 184 is located on the proximal end of the first needle170. Similarly, a second ball end 186 is located on the proximal end ofthe second needle 172. The second and first ball ends 186, 184 may beinserted into a side opening 188 in the handle 160. A top needle slot190 allows the needles 170, 172 to move into the handle 160, and thenthe needles 170, 172 can be pivoted down into forward slots 192, 194,respectively, also formed in the handle 160. This couples the needles170, 172 to the handle 160. The forward slots 192, 194 maintain thehorizontal needle spacing at the proximal end of the device.

The pivot point 162 of the handle 160 may be aligned in a pivot boss 198formed in the housing 158. The shaft holders 168 may be held andsupported by a variety of features on the inside of the housing 158.Such features are not illustrated for simplicity, but are well known tothose skilled in the art. Although only one half of the housing 158 isshown in this exploded view, it should be understood that acomplementary half of the housing is also present (though not shown) andwould have similar boss features to allow pivoting of the handle 160 andbracing of the shaft holders 168.

The hard stop 167 may be mounted in a hard stop boss 196 to limit travelof the handle 160, while a lower end 200 of spring 164 may be coupled toa fixed spring attachment point 202 on the housing. An upper end 204 ofthe spring 164 may be hooked onto a handle spring attachment point 206.

FIG. 4A is an enlarged perspective view of one embodiment of a needleguide tube 176 for a prosthetic suturing device. FIGS. 4B, 4C, and 4Dare side, back, and front elevational views, respectively, of the needleguide tube 176 of FIG. 4A. In this embodiment, the needle guide tube 176has a first spiral track 178 and a second spiral track 180. Looking atthe back view of FIG. 4C, it can be seen that the spiral tracks 178, 180will receive the first and second needles (not shown in this view) in ahorizontal alignment from a proximal end of the device. Looking at thefront view of FIG. 4D, it can be seen that the spiral tracks 178, 180will have guided the needles into a vertical alignment near the guidetip (not shown in this view). The spiral tracks 178, 180 can providesupport for a thinner needle so that the needles do not buckle whenrotated to a different orientation. The needle guide tube 176 may alsohave a keyed portion 208 for mating with and/or aligning with acorresponding feature on the guide tip to ensure the needles exit theneedle guide tube 176 and pass smoothly into the guide tip 152.

FIGS. 5 and 6 are enlarged perspective views of one embodiment of aguide tip 152 for a prosthetic suturing device shown from distal andproximal perspectives, respectively. Passages pass within the proximalend 152P of the guide tip 152, guiding the first and second needles 170,172 towards first and second needle guides 210, 212, respectively. Theneedle guides 210, 212 help to guide the needles 170, 172 through thecuff receiving area 154 defined by the guide tip 152.

The guide tip 152 also has first and second adapter receiving apertures214, 216, located in the distal end 152D of the guide tip 152. Theadapter receiving apertures 214, 216 are configured to hold first andsecond suture adapters 218, 220, respectively. The suture adapters 218,220 may each be coupled to a different end of a suture 222. The sutureadapters 218, 220 are designed to be engaged by the ends 170E, 172E ofthe first and second needles, respectively, such that the needles 170,172, when contacting the adapters 218, 220 will be able to pull theadapters 218, 220 (and therefore, the ends of the suture 222) backthrough the cuff receiving area. One non-limiting example of suitableadapters include ferrules into which the needle tips 170E, 172E may bepressed. For convenience, this specification will refer to the adapters218, 220 as ferrules. Similarly, the specification will also refer tothe adapter receiving apertures 214, 216 as ferrule holders, but itshould be understood that the broader interpretations apply where theclaims are concerned, unless otherwise specified.

The distal end 152D of the guide tip 152 also defines first and secondsuture removal passages 234, 236 which are in communication with thefirst and second ferrule holders 214, 216. The removal passages 234, 236allow the suture 222 which is coupled to the ferrules 218, 220 to berouted out the distal end 152D of the device after the ferrules 218, 220are placed into the ferrule holders 214, 216.

The ferrule receiving apertures 214, 216 each have flared ends facingthe cuff receiving area 154. As will be shown and discussed in moredetail later in this specification, a sewing cuff of a replacement heartvalve will be placed into the cuff receiving area, and then the needles170, 172 will be advanced, piercing the sewing cuff and continuing on tocouple with the ferrules 218, 220 before being withdrawn to pull thesuture ends back through the sewing cuff. The sewing cuff material willtend to be pushed into the ferrule receiving apertures 214, 216, so theflared ends are helpful in preventing the sewing cuff material frombecoming jammed between the needles 170, 172 and their respectiveferrule receiving apertures 214, 216.

This embodiment of a guide tip 152 also has many different alignmentguides for helping a user to visualize where the needles (which aremainly hidden from the user) will contact the sewing cuff. For example,the guide tip 152 has a first proximal horizontal needle alignment guide224P adjacent the first needle guide 210. Similarly, the guide tip 152has a second proximal horizontal needle alignment guide 226P adjacentthe second needle guide 212. The guide tip 152 also has a first distalhorizontal needle alignment guide 224D and a second distal horizontalneedle alignment guide 226D adjacent the first and second ferrulereceiving apertures 214, 216, respectively. As a sewing cuff is movedhorizontally in relation to these horizontal needle alignment guides224P, 224D, 226P, 226D, the intended horizontal penetration location ofthe needle relative the cuff can be judged from the alignment guides.

The guide tip 152 also has a first proximal vertical needle alignmentguide 228P adjacent the first needle guide 210. Similarly, the guide tip152 has a second proximal vertical needle alignment guide 230P adjacentthe second needle guide 212. The guide tip 152 also has a first distalvertical needle alignment guide 228D and a second distal vertical needlealignment guide 230D adjacent the first and second ferrule receivingapertures 214, 216, respectively. As a sewing cuff is moved verticallyin relation to these vertical needle alignment guides 228P, 228D, 230P,230D, the intended vertical penetration location of the needle relativethe cuff can be judged from the alignment guides.

The guide tip 152 also has a left central alignment guide 232L and aright central alignment guide 232R which are located on a planesubstantially central to the first and second ferrule holders 214, 216for further needle visualization.

FIG. 7B is a partially cross-sectioned side view of the prostheticsuturing device 150 of FIG. 2B with the needles 170, 172 in a retractedposition. FIG. 7A is a top view of the device 150 from FIG. 6B, hidingthe handle, housing, spring, and hard stop in order to more clearly showthe proximal needle orientation. In this embodiment, on the proximalend, the needles 170, 172 are oriented in a horizontal row, but they arespiraled inside the device to be aligned to pass vertically into thecuff receiving area 154. In the retracted position of FIG. 7B, the endsof the needles 170, 172 are located just inside the guide tip 152 on theproximal side of the cuff receiving area 154.

FIG. 8B is a partially cross-sectioned side view of the prostheticsuturing device 150 of FIG. 2B, with the ends of the needles 170E, 172Ein a partially engaged position as they pass through the cuff-receivingarea 154. FIG. 8A is a top view of the device from FIG. 8B, hiding thehandle, housing, spring, and hard stop in order to more clearly shownthe proximal needle orientation. The handle 160 has been moved 174toward the housing grip 175, causing the needles 170, 172 to be moved ina distal direction 238.

FIG. 9B is a partially cross-sectioned side view of the prostheticsuturing device 150 of FIG. 2B, with the ends of the needles 170E, 172Ein a fully engaged position and coupled to the suture ferrules 218, 220held in the distal end of the guide tip 152. FIG. 9A is a top view ofthe device from FIG. 9B, hiding the handle, housing, spring, and hardstop in order to more clearly show the proximal needle orientation. Thehandle 160 has contacted the hard stop 167 to prevent the needles 170E,172E from pressing too hard into the ferrules 218, 220.

FIG. 10B is a partially cross-sectioned side view of the prostheticsuturing device 150 of FIG. 2B, with the needles 170, 172 partiallyretracted and pulling the suture ferrules 218, 220 and suture 222 backthrough the cuff receiving area 154. FIG. 10A is a top view of thedevice from FIG. 10B, hiding the handle, housing, spring, and hard stopin order to more clearly show the proximal needle orientation. Thehandle 160 has been partially released, and the spring 164 has causedthe handle to move 242 away from the housing grip 175, thereby causingthe needles 170, 172 to move in a proximal direction 240.

FIG. 11B is a partially cross-sectioned side view of the prostheticsuturing device 150 of FIG. 2B, with the needles 170, 172 fullyretracted. FIG. 11A is a top view of the device from FIG. 11B, hidingthe handle, housing, spring, and hard stop in order to more clearly showthe proximal needle orientation. The position of the needles 170, 172 inFIG. 11B is the position the needles 170, 172 take when the user is notapplying force to the handle 160. FIG. 11C is an enlarged partialcross-sectional view of the guide tip 152 from FIG. 11B, showing theferrules 218, 220 coupled to the ends of the needles 170E, 172E beingheld distally to the ferrule removal spring 182. The ferrule removalspring 182 has a first edge 244 which rides on the first needle 170 andwhich is positioned to push the ferrule 218 off of the first needle 170if the needle 170 is moved more in a proximal direction. The ferruleremoval spring 182 also has a second edge 246 which rides the secondneedle 172 and which is positioned to push the ferrule 220 off of thesecond needle 172 if the needle 172 is moved more in a proximaldirection. As it stands in the view of FIG. 11C, however, the ferrules218, 220 are still coupled to their respective needle ends 170E, 172E.The suture 222 has been pulled through the cuff receiving area 154 on apath where the needles 170, 172 had been pulled back. As will be shownand described in later figures, if there had been a sewing cuff locatedin the cuff receiving area, the suture 222 would have been pulled backthrough the sewing cuff in two locations (where the first and secondneedles 170, 172 had passed).

The view of FIG. 11C also offers a cross-sectional look at the first andsecond ferrule receiving apertures 214, 216. The flared end 248 of thefirst ferrule receiving aperture 214 and the flared end 250 of thesecond ferrule receiving aperture 216 can be seen more clearly in thisview.

FIG. 12B is a partially cross-sectioned side view of the prostheticsuturing device 150 of FIG. 2B, with the needles 170, 172hyper-retracted. FIG. 12A is a top view of the device from FIG. 12B,hiding the handle, housing, spring, and hard stop in order to moreclearly show the proximal needle orientation. In FIG. 12B, the user hasapplied a force to the handle 160 in a direction away 242 from the grip175. The handle 160 may contact the handle stop 166 which can bedesigned to flex or give in order to allow the handle to move in thisdirection 242. This causes the needles 170, 172 to retract more than thenormal resting state of FIG. 11B in a proximal direction 240. FIG. 12Cis an enlarged partial cross-sectional view of the guide tip 152 fromFIG. 12B, showing what happens when the needles 170, 172 arehyper-retracted in this fashion. The ferrules 218, 220 are decoupledfrom the ends of the needles 170E, 172E after having been pushed off ofthe needles 170E, 172E by the ferrule removal spring 182. This allowsthe suture to be removed from the device 150, and a new set of ferrulesmay be loaded into the device. This can be helpful in a cardiac surgerywhere there are often many pairs of suture ends which have been sewninto tissue and which then have to be sewn into corresponding positionsin a sewing cuff of a replacement anatomical structure.

FIG. 13 is an exploded perspective view of another embodiment of aprosthetic suturing device 251. The main difference between thisembodiment and the previous embodiments is that the needles retain avertical alignment throughout, rather than starting in a horizontalalignment and then being twisted into a vertical alignment. A needleguide tube 252, this one having a first straight track 254 and a secondstraight track 256, is placed into a proximal end 257P of shaft 257. Aguide tip 152 is placed into a distal end 257D of the shaft 257, and anotch 258 of the needle guide tube 252 is aligned with a key 260 of theguide tip 152 inside of the shaft 257. A shaft holder 262 is coupled togrooves 264 of the shaft 257.

A drive rod 266 has a ball end 268 on a proximal end of the drive rod266. The distal end of the drive rod 266 is coupled to a drive block270. The ball end 268 of the drive rod 266 is placed into a side opening272 in the handle 274, while the drive rod is pulled across a top slot276 and down a forward slot 278 in the handle. A first needle 280 has anend 280E configured to engage a suture adapter, such as a ferrule. Thefirst needle 280 also has a proximal needle end 280P. A second needle282 has an end 282E configured to engage a suture adapter such as aferrule. The second needle 282 also has a proximal needle end 282P. Thesecond needle 282 is placed into the second straight track 256 of theneedle guide tube 252, end 282E first. The ferrule release spring 182may be placed into a slot in the top of the guide tip 152 and rested onthe second needle 282. The first needle 280 may then be placed into thefirst straight track 254 of the needle guide tube 252, end 280E first,so that the spring 182 is compressed between the two needles 280, 282 asin previous embodiments.

A needle connector 284 has first and second connector holes 286, 288into which the proximal ends of the first and second needles 280P, 282Pare placed, such that the proximal ends 280P, 282P are coupled to theirrespective connector holes 286, 288. The needle connector 284 is coupledto a connector receptacle 290 in the drive block 270, completing thelink between the needles 280, 282 and the handle 274.

The pivot point 162 of the handle 274 may be aligned in a pivot boss 198formed in the housing 158. The shaft holder 262 may be held andsupported by a variety of features on the inside of the housing 158.Such features are not illustrated for simplicity, but are well known tothose skilled in the art. Although only one half of the housing 158 isshown in this exploded view, it should be understood that acomplementary half of the housing is also present (though not shown) andwould have similar boss features to allow pivoting of the handle 274 andbracing of the shaft holder 262.

The hard stop 167 may be mounted in a hard stop boss 196 to limit travelof the handle 274, while a lower end 200 of spring 164 may be coupled toa fixed spring attachment point 202 on the housing. An upper end 204 ofthe spring 164 may be hooked onto a handle spring attachment point 206.

FIG. 14 is a partially exposed side view of the prosthetic suturingdevice 251 of FIG. 13. When the handle 274 is squeezed 292 towards thegrip 175, the first and second needles 280, 282 are moved distallythrough the cuff receiving area 154 in a manner as shown in the previousembodiments.

FIG. 15 is a perspective view of one embodiment of a guide tip 152 for aprosthetic suturing device. Most features of this embodiment of a guidetip 152 have been discussed above, however, this embodiment can also beseen to have first and second proximal needle guides 294, 296. Theseguides 294, 296 work with the needle guides 210, 212 (not visible inthis view, but discussed previously) in order to help guide the needles280, 282 through the cuff receiving area while maintaining an expectedvertical alignment and spacing between the needles 280, 282.

Depending on the embodiment, the needle guides 294, 296 in the guide tip152 may be used to force needles which start horizontally into avertical alignment without the need for a needle guide tube. FIG. 16illustrates just such an embodiment, and is a partially exposed partialcross-sectional perspective view of another embodiment of a prostheticsuturing device 298, utilizing the guide tip of FIG. 15 without a needleguide tube. The features of this embodiment are just like those of theembodiment of FIG. 2B, however, this device 298 does not use the aneedle guide tube. Instead, the needles 170, 172 start horizontally asheld by the handle 160, but are then twisted into vertical orientationby the guide tip 152. In order to prevent the needles from buckling, itmay be necessary to go with a heavier gauge needle when a suture guidetube is not used.

FIG. 17 is a partially exposed side view of a further embodiment of aprosthetic suturing device 300. This embodiment only has a single needle302 and a place for a corresponding ferrule holder in the guide tip 304,but the cuff receiving area is still facing left while the handle 160and grip 175 substantially point down (as in previous embodiments).

FIG. 18 is a partially exposed side view of another embodiment of aprosthetic suturing device 306. In this embodiment, the guide tip 308has a vertical opening (rather than a horizontal opening like previousembodiments) which defines a cuff receiving area. The needles 170, 172in this embodiment are aligned horizontally, and otherwise, this deviceoperates like the previous embodiments.

FIGS. 19A-19F illustrate one example of a surgical usage of anembodiment of a prosthetic suturing device. For convenience, only theguide tip 152 of the device is shown in FIGS. 19A-19F. The guide tip 152is like that of FIGS. 5 and 6, and as noted in the examples above, thereare many actuator examples which would result in the vertically alignedneedles 170, 172 illustrated here. The surgical situation of thisexample is as follows, and as illustrated in FIG. 19A: In preparationfor installation of a replacement anatomical structure 312 (here,illustrated as a replacement heart valve), a suture 222 has been sewnthrough a tissue 315 inside of a patient. This could have been done byhand, but preferably with a minimally invasive suturing device which iscompatible with ferrules (or some other type of suture adapter). Theferrules 218, 220 were removed from the minimally invasive suturingdevice and then loaded into the ferrule holders in the distal end of theguide tip 152 outside of the patient. The replacement anatomicalstructure 312, having a sewing cuff 314, is standing by.

As shown in FIG. 19B, the sewing cuff 314 of the replacement valve 312is placed 316 into the cuff receiving area 154 of the guide tip 152. Asdescribed previously, the needle alignment guides can be used to helpposition the sewing cuff as desired. Since the cuff receiving area facesto the side, while the handle and grip face substantially downward, itis easier for a surgeon to hold the suturing device with one hand whilepositioning the valve 312 with the other hand. As shown in FIG. 19C, thedevice handle (not shown) is squeezed to cause the needles 170, 172 tomove distally 318, pierce the sewing cuff 314, and then engage theferrules 218, 220 with respective ends 170E, 172E of the needles 170,172. As shown in 19D, the device handle (not shown) is released to causethe needle ends 170E, 172E to move proximally 320 back through thesewing cuff 314, pulling the ferrules 218, 220 and the suture 222 backthrough the sewing cuff as well. As shown in FIG. 19E, the replacementanatomical structure 312 can be removed 322 from the from the cuffreceiving area 154 while the ferrules 218, 220 remain coupled to theneedles 170, 172 in the proximal end of the guide tip 152. Although thesuture 222 is still illustrated as passing through the ferrule holdersin the distal end of the device, it should be understood that the suture222 can be removed from the ferrule holders by passing it through thesuture removal passages 234, 236. As shown in FIG. 19F, the needles 170,172 may be further moved in a proximal direction 324 (as discussedabove) so that the ferrules 218, 220 are pushed off of the needles 170,172 by the ferrule removal spring 182, thereby releasing the ferrules218, 220 to move free 326 of the device. By loading other suture endsinto the device, this process can be repeated with other suture pairsaround the circumference of the sewing cuff 314. This device and methodgreatly simplify and speed up the process of placing sutures through asewing cuff of a replacement anatomical structure. Once the desirednumber of suture ends have been passed through the sewing cuff, thoseskilled in the art know how to run the replacement anatomical structuredown the sutures and against the tissue where the sutures were firstplaced. The pairs of suture ends may then be tied off with hand-tied ormechanical knots as desired.

FIG. 20A is a perspective view of one embodiment of a surgical suturingdevice 328 and one embodiment of a magazine 330 for the surgicalsuturing device 328. The surgical suturing device 328 has a housing 332and an actuator 334 (only the lever handle 336 of which may be seen inthis view). The suturing device also has a tip 338 which has a suturemagazine receiver 340. The suturing device 328 also has an indexer. Mostof the features of the indexer cannot be seen in this view, with theexception of the indexer's push button 342 which can be seen in thisview. The indexer is operationally coupled to the suture magazinereceiver 340 to be able to move the suture magazine 330 (once installed)from one suturing position to another. This indexing movement will bediscussed in more detail in later views. In FIG. 20A, the magazine 330is shown separated from the surgical suturing device. In FIG. 20B, themagazine 330 is shown installed in the suture magazine receiver 340 ofthe suturing device. Details of the magazine 330 will be discussed inmore detail later in this description.

FIG. 21 is an exploded view of the surgical suturing device of FIG. 20A.For assembly, a pair of needles 342A, 342B is passed down through anopening 344 in the push button 342 (push control) where they can beinserted into a needle receiver 346 in the actuator handle 336. A needlepin 348 (which may be pre-attached to the two needles) holds the needlespivotably in place in the handle 336. The distal end of the needles350A, 350B rests in needle guides 352A, 352B formed by middle 354 andtop 356 portions of the device tip which are coupled together around theneedles 342A, 342B. A forward stop 358 and a stop spring 360 are setinto respective grooves of a bottom portion 362 of the device tip. Anindexing flexure 364 is coupled to a pusher 366 which is then set into apushing channel 368 of the tip bottom. For later reference, the indexingflexure 364 has a primary cam 370 and the pusher 366 has a secondary cam372. A pusher spring element 374 is slid over the proximal end 376 ofthe pusher 366 and the proximal end 376 of the pusher 366 is coupled tothe push button 342. The pusher spring 374 is compressed between theforward end 378 of the push button 342 and a pusher spring receiver 380of the tip formed when the bottom 362 of the tip is coupled to themiddle 354 of the device tip. A pivot point 382 of the handle 336 isaligned with pivot bosses 384 of the housing 332 as the two portions ofthe housing 332 are brought together. The housing 332 also holds the tip338 (made of upper, middle, and lower portions 356, 354, and 362) andprovides a slideable guide for the push button 342.

FIG. 22 is an exploded view of the suturing magazine 330 of FIG. 20A. Ithas a plurality of suturing positions 386A-386F. In this embodiment,each suturing position 386A-386F has two ferrule holders 388A, 388B tocorrespond to the two needles 342A, 342B of the suturing device 328.Other embodiments may have more or fewer ferrule holders in eachsuturing position. A ferrule holder is configured to hold a ferrulewhich is attached to the end of a suture. A ferrule is an object whichcan be picked up by a needle which comes into contact with it.Embodiments of ferrules will be discussed further below. In many cardiacsurgical procedures, the sutures which have been sewn into the hearttissue where a replacement valve will be anchored will often haveferrules attached to their ends. The suture ferrules can be installed bya surgeon, or someone on his/her staff, into the ferrule holders 388A,388B of the magazine. In this embodiment, the ferrules on two ends ofthe same suture may be placed into ferrule holders 388A, 388B of thesame suture position in the magazine. The positions 386A-386F in amagazine may be filled in order so that the suture ends are managed,tracked, and kept untangled. Although this embodiment shows a magazinewith six suture positions 386A-386F, other embodiments may have fewer ormore suture positions.

As will be seen in the discussion below, after the magazine 330 has beeninserted into a suturing device 328, the needles 342A, 342B can traverseover the magazine 330 on their way to the ferrules which are held in theferrule holders 388A, 388B. In order to help keep the needles 342A, 342Baligned with the ferrules as the needles 342A, 342B move, thisembodiment of the magazine 330 has two needle alignment guides 390A,390B in line with each ferrule holder 388A, 388B, respectively. Otherembodiments may have fewer or more alignment guides for each needle.

The magazine 330 has a ferrule remover 392 and a ferrule gate 394 whichare spaced apart and held in place by a ferrule capture 396. In thisembodiment, the ferrule gate 392 is a distal ferrule spring and theferrule remover 394 is a proximal ferrule spring. The ferrule remover394 and the ferrule gate 392 may each be a series of separate componentsor one continuous component. The operation of the ferrule gate 392, theferrule remover 394, and the ferrule capture 396 will be discussed inmore detail below, but it should be noted that the ferrule capture 396may advantageously be made of a transparent or translucent material insome embodiments to facilitate observation of ferrules which shouldbecome captured therein. A sewing cuff receiver 398 is located betweenthe ferrule holders 388A, 388B and the ferrule capture 396.

This embodiment of a magazine also has a cutter 400 which can be held ina portion of the magazine 330 for convenient cutting of sutures whenneeded. The cutter 400 can be recessed to avoid injury to the peoplehandling the magazine 330 or to the patient. Other embodiments may nothave a cutter.

This embodiment of the magazine 330 further has one or more directionindicators 402 to assist the operator in determining the correctdirection to insert the magazine 330 into the suturing device.

Embodiments of the magazine will also have an indexable featureconfigured to enable the magazine to be moved between the plurality ofsuturing positions. The indexable feature can include, but is notlimited to, one or more of the following features: one or more primarycam paths, one or more secondary cam paths, and/or one or more stopreceivers, examples of which will be discussed in more detail below.Other embodiments of the indexable feature may include a gear rack.

FIGS. 23A-23F show top, front, left, right, bottom, and rear(upside-down) elevational views, respectively, of the magazine of FIG.22. In addition to the features already discussed, the primary cam paths404A-404F, the secondary cam paths 406A-406F, and stop receivers408A-408F can be seen more clearly. A receiver mating 410 feature isalso visible. Some embodiments may not have a receiver mating feature,but a magazine's receiver mating feature is configured to engage acorresponding magazine mating feature in the magazine receiver of thesuturing device.

FIG. 24 shows an embodiment of the magazine 330 inserted into themagazine receiver 340 of the suturing device 328. One half of thehousing 332 has been removed, along with the middle and top portions ofthe tip so that some of the hidden elements may more clearly be seen.The tip of the stop spring 360 has engaged the first stop receiver 408Aon the magazine, and the first suturing position 386A is in alignmentwith the two device needles 342A, 342B. The stop spring 360 may be seenmore clearly in the exposed top view of FIG. 25A, showing the sewingdevice from the top. The ramped shape of the tip 412 of the stop spring360 facilitates movement of the magazine 330 (when installed) in asingle direction if an external force is applied. Additionally, theforward stop 358 is normally protruding upward into a stop receiver onthe bottom of the magazine. The forward stop 358 may be seen moreclearly in the exposed side view of FIG. 25B. The tip 414 of the forwardstop 358 rises into the suture magazine receiver 340 to help hold themagazine in a given suturing position, but the forward stop may bedisengaged, as will be discussed in more detail below.

Ferrules may be loaded into the magazine either after, or preferablybefore, the magazine is inserted into the suturing device. FIG. 26Aillustrates a partial cross-sectional side view of a magazine 330 havinga ferrule 416A loaded into a suture holder 388A. The magazine 330 isloaded into the suturing device to the first suturing position, and thevisible needle 342A is aligned with the ferrule 416A in the ferruleholder 388A. The ferrule remover 394 and the ferrule gate 392 areprotruding slightly into a passage 418 of ferrule capture. A replacementanatomical device 420 (in this example, a replacement heart valve) hasbeen placed into a sewing cuff receiver 398 of the magazine 330.

In FIG. 26B, the needle 342A has been actuated in a distal direction422, causing it to pass against the ferrule remover spring 394 (pushingit down), pass through the passage 418 in the ferrule capture, passagainst the ferrule gate spring 392 (pushing it down), pass through thesewing cuff 424 of the replacement valve 420, and into contact with theferrule 416A at the end of the suture 426. In this embodiment, the tipof the needle fits within the ferrule and holds onto the ferrule.

In FIG. 26C, the needle 342A has been partially withdrawn in a proximaldirection 428 so that the ferrule 416A and its attached suture 426 arepulled back through the sewing cuff 424, over the ferrule gate spring392, and into the passage 418 of the ferrule capture. The ferrule 416Aheld by the needle 342A tip in the ferrule capture 418 may be seen moreclearly in the enlarged view of FIG. 26D-1. In the enlarged view of FIG.26D-2, as the needle 342A continues in a proximal direction, an edge ofthe ferrule remover spring 394 catches on the lip of the ferrule 416Aand starts to remove the ferrule 416A from the needle's 342A tip. Asshown in FIG. 26E, as the needle 342A continues in the proximaldirection 428, the ferrule 416A is completely removed from the needle342A and held in the ferrule capture 418. The ferrule trap ensures thatthe ferrule does not pull back out of the ferrule capture 418, even ifthe suture 426 attached thereto is pulled.

FIGS. 27A-27H show a similar sewing process for a single suturingposition in a partially exposed view which highlights the dual needleembodiment. FIG. 27G illustrates the magazine 330 having been indexed toa second suturing position, and the replacement valve is being rotatedand placed back into the sewing cuff receiver so that the needles maypenetrate the sewing cuff at another position to pull the second sutureset back through. The second stitch would occur much like the first,just with a second set of ferrules attached to the ends of a secondsuture.

FIGS. 28A-28G schematically illustrate one embodiment of how the indexerportion of the suturing device and the indexable feature of the magazinework together to index or move the magazine from one suturing positionto another. The viewpoint of FIGS. 28A-28G is from the bottom of thedevice, and for clarity, the device tip is shown as being transparentwith visible edges so the features of the magazine behind it may moreclearly be seen with solid lines. For simplicity, certain portions ofthe device are not shown in FIGS. 28A-28G to provide clarity to theexplanation.

In FIG. 28A, the primary cam 370 of the indexing flexure 364 is seenresting in its track 430 of the device tip 338 in a retracted position,while the pusher 366 and the secondary cam 372 coupled to it are also inretracted positions. We can tell the magazine 330 is in a first suturingposition because the stop spring 360 is engaged in the first stopreceiver 408A on the side of the magazine. The tip 414 of the forwardstop 358 is also engaging a depression in the magazine.

In FIG. 28B, the pusher 366 has started to move in a distal 432direction, causing the primary cam 370 to move into contact with theprimary cam path 404A of the magazine 330. Additionally, the forwardportion 434 of the pusher 366 engages the forward stop 358, pushing itout of engagement with the magazine 330 (This movement of the forwardstop 358 is towards the viewer in the orientation of FIG. 28B, away fromthe magazine 330 so that the tip of the forward stop no longer engagesthe depression in the magazine).

In FIG. 28C, the pusher 366 continues to move distally 432, and theinterference of the primary cam 370 with a ramped wall of the primarycam path 404A causes the magazine 330 to start to move in a directionlateral 436 to the pusher movement The secondary cam 372 on the pusher366 also is aligned to enter the secondary cam path 406A defined by themagazine 330. Since the magazine 330 is moving, the stop spring 360 hasbeen pushed out of the stop receiver 408A in the magazine 330.

In FIGS. 28D and 28E, the pusher 366 continues moving in a distaldirection, causing the primary and secondary cams 370, 372 to move downthe primary and secondary cam paths 404A, 406A, respectively, resultingin more lateral movement 436 of the magazine.

In FIG. 28F, the pusher 366 continues moving in a distal direction 432,causing the primary and secondary cams 370, 372 to move onto respectiveportions of the primary and secondary cam paths 404A, 406A which areparallel 438 to the motion of the pusher 366. At this point, the lateralmovement of the magazine will stop, even if the pusher 366 continues tomove forward as in FIG. 28G. The stop spring 360 has engaged the secondstop receiver 408B, and the indexing movement has been accomplished inthis embodiment with just the distal movement of the pusher 366.Although not shown in this view, the needles are now aligned with thesecond set of ferrules in the second suturing position. If pressure onthe pusher 366 is released, the pusher spring (not shown here) willretract the pusher and the primary and secondary cams 370, 372. Theindexing may then be repeated as desired.

Thus far, all of the illustrated embodiments show separate controls forneedle actuation and indexing. The handle lever actuates the needles andthe push button (coupled to the pusher) causes a magazine to index.However, as will be apparent to those skilled in the art, it is possibleto have both functions controlled by a single actuator. As one example,energy could be stored in an energy storage spring as the lever issqueezed. Then, as the lever is released, and once the needles wereclear of the magazine, the energy stored in the storage spring could beused to drive the indexing movement. In other embodiments, movement ofthe lever in a first direction could engage the needles, which might bespring biased to automatically retract at the end of a lever stroke.Movement of the lever back to the starting direction could causeindexing to occur.

Furthermore, the indexing and needle actuation could be accomplished ina wide variety of other ways. All manner of alternatives will beapparent to those skilled in the art upon reading this specification. Assome non-limiting examples, the actuator or the indexer may include oneor more levers, gears, pulleys, friction wheels, solenoids, motors, orany combination thereof. When those skilled in the art consider otheractuator embodiments, such as electronically controlled actuators, manyways will become apparent for a single “actuator”, from the user's pointof view, to instigate the needle actuation and the magazine indexing,rather than having two manual controls.

FIG. 29 is a side view of another embodiment of a magazine 440 for asuturing device. While the sewing cuff receiver of the previouslydiscussed embodiments was symmetrical from a side view, this embodimenthas an asymmetrical sewing cuff receiver 442 when viewed from this sideview. Depending on the embodiment, the shape of the sewing cuff receiver442 may be designed to conform to the shape of a particular sewing cuff.In some embodiments, the sewing cuff receiver may have a ramp 444,curve, or slope to enable surgeons to prop the sewing cuff insertedtherein at a desired height, thereby offering surgeons more control oversuture placement.

FIGS. 30A, 31A, 32A, and 33A schematically illustrate different sideviews of a suture magazine receiver 446, 448, 450, 452, respectively, ina suturing device (only the device tip is pictured). Each of thedifferent embodiments in FIGS. 30A, 31A, 32A, and 33A has a magazinereceiver with a differing number of receiving surfaces. The magazinereceiver 446 of FIG. 30A has four receiving surfaces 446A, 446B, 446C,446D. The magazine receiver 448 of FIG. 31 has three receiving surfaces448A, 448B, 448C. The magazine receiver 450 of FIG. 32A has tworeceiving surfaces 450A, 450B. The magazine receiver 452 of FIG. 33A hasone receiving surface 452A. The receiving surfaces can help guide amagazine when inserted therein. FIGS. 30A, 31A, 32A, and 33A alsoinclude different embodiments of magazine mating features 454, 456, 458,460, 462. The magazine mating features can be protruding 454, 456, 458,460, or they can be inset 462, or any combination thereof. Any number(zero or greater) of magazine mating features may be included in themagazine receiver. The magazine mating features may have any desiredshape, and not all mating features need to be used for any givenmagazine, depending on the embodiment. This might enable a singlesuturing device to interact with different magazines having a variety ofdifferent corresponding mating features.

FIG. 30B illustrates one embodiment of a suture magazine 464 installedin the suture magazine receiver of FIG. 30A. FIG. 31B illustrates oneembodiment of a suture magazine 466 installed in the suture magazinereceiver of FIG. 31A. FIG. 32B illustrates one embodiment of a suturemagazine 468 installed in the suture magazine receiver of FIG. 32A. FIG.33B illustrates one embodiment of a suture magazine 470 installed in thesuture magazine receiver of FIG. 33A. Each magazine in FIGS. 30B, 31B,32B, and 33B has one or more receiver mating features which correspondto the magazine mating features of the magazine receiver. For example,magazine 464 has receiver mating feature 472 which corresponds tomagazine mating feature 454. Magazine 466 has receiver mating feature474 which corresponds to magazine mating feature 456. Magazine 468 hasreceiver mating feature 476 which corresponds to mating feature 458.Magazine 470 has receiver mating features 478, 480 which correspond tomagazine mating features 460, 462, respectively.

FIG. 34A illustrates one embodiment of a surgical suturing device 482having a cassette receiver 484. FIG. 34B is the surgical suturing device482 of FIG. 34A in a partially exposed view. A handle 486 is pivotablearound a pivot point 488 supported by the housing 490. A spring 492coupled between the handle 486 and the housing 490 biases the handle 486away from a grip 494. Two needle drivers 496 are coupled to the handle486. The needle drivers 496 extend through a receiver component 498,ending in a cassette receiver 484. The ends 500 of the needles drivers496 are visible in the cassette receiver 484.

FIG. 35 is an exploded view of the surgical suturing device of FIG. 34A.The needle drivers in this embodiment each have two components: aproximal component 502 for coupling to the handle 486 and a distalcomponent 504 that connects to the proximal component. There are twosets of proximal and distal components 502, 504 which make up the needledrivers. Each proximal component 502 has a first mating feature 502Mwhich is passed through an opening 506 in the receiver component 498.Each distal component 504 of the needle drivers has a second matingfeature 504M which is inserted into a corresponding guide slot 508 inthe cassette receiver 484 side of the receiver component 498 where therespective mating features 502M, 504M for each needle driver are thencoupled together inside the receiver component 498.

Each proximal component 502 of the needle drivers has a respective ball510 which is fits into a respective hole 512 of the handle 486 while theproximal components 502 are in an upright position (perpendicular to theorientation shown in FIG. 35). Only one of the holes 512 is visible inthis view, but the other hole 512 is symmetrically placed on theopposite side of the handle 486. Once the balls 510 have been placedinto the holes 512, the proximal components 502 of the needle driverscan be maneuvered down into slots 514. The pivot point 488 extends toboth sides of the handle 486 and is aligned within a pivot boss 516 ofthe housing 490. The receiving component 498 has features 518 (one ofwhich is visible in this view) which are configured to be held bycorresponding features in the housing 490. Such alignment features areknown to those skilled in the art and are not shown in the housing 490for simplicity. The housing 490 also has an opening 520 which isconfigured to help align the receiver component 498. The spring 492 isattached between a hook 522 on the handle 486 and a post 524 which ispart of the housing 490. The spring 492 pulls on the hook 522, causingthe handle 486 to rotate around the pivot point 488 until the handle 486contacts a stop 526 on the housing 490. When in use, the handle 486 willbe squeezed towards the grip 494. A motion limiter 528 is installed intoa corresponding receiver 530 in the housing 490. The motion limiter 528provides a limit to the range of motion of the squeezed handle 486. Onlyone half of the housing 490 is shown in the exploded view of FIG. 35,but a corresponding half (not shown) aligns with the pivot point 488,the motion limiter 528, and the receiver component 498 while coupling tothe half of the housing 490 which is shown to complete the assembly.

FIG. 36 is an enlarged, exposed view of the ends 500 of the needledrivers 496 in an exposed view of a portion of the surgical suturingdevice of FIG. 34A. The end 500 (distal) of each needle driver 496 has aneedle receiver 532. FIG. 37 is an enlarged view of the needle receivers532 and the cassette receiver 484 of the surgical suturing device ofFIG. 34A. The cassette receiver 484 has pivot receivers 534, a needlerelease 536, multiple alignment slots 538, and multiple retentionfeatures 540 which will be discussed in more detail below.

FIGS. 38A and 38B are different perspective views of a cassette 542embodiment for use with the surgical suturing device of FIG. 34A. Thecassette 542 houses two needles (not visible in this view) within a base544 and a cover 546 which are coupled together. It is one advantage ofthis system that the needles are kept inside the cassette 542 because itreduces the opportunity for the surgical staff and surgeon to be cutduring an operation by an exposed sharp needle. By necessity, patientsare treated as though their blood carries harmful pathogens, so it isalways disconcerting when someone on a surgical team is cut or poked bya needle. By keeping the needles within the cassette 542, away fromskin, surgical procedures involving this cassette can be safer. Thereare a variety of ways the base 544 and cover 546 can be coupledtogether, including, but not limited to by latching, by gluing, and bywelding. In this embodiment, the base 544 has multiple base latches 548which engage slots in the cover 546, as well as multiple cover latches550 which engage slots in the base 544. The cassette 542 has multiplepivots 552 (one of which is visible in FIGS. 38A, 38B, but the other issymmetrically located on the opposite side). The cassette 542 also hasan alignment tab 554 on each side of the cassette 542. The cover 546 hastwo flexible arms 556 which may be pinched inwardly. Each of theflexible arms 556 has a retention latch 558 (one of which is visible inFIG. 38A, but the other is symmetrically located on the other flexiblearm). The base 544 has two proximal openings 560 where the proximal endsof the needles (not shown) inside the cassette 542 are accessible. Inother embodiments, the two proximal openings 560 may be combined intoone shared proximal opening 560 by removing the dividing piece 562between the two openings 560. The base 544 also has two distal openings564 from which distal ends of the needles (not shown) may be extended.The cover 546 defines two ferrule holders 566 and two exit slots 568 forsuture coupled to ferrules. Ferrules are not installed in the cassetteof FIGS. 38A, 38B. The base 544 and cover 546 work together to define acuff receiving area 570 between the distal openings 564 and the ferruleholders 566. The base 544 also defines a release slot 572 which is sizedto allow the needle release from the cassette receiver (see FIG. 37) topass.

FIG. 39 is an exploded view of the cassette 542 of FIG. 38A whichenables us to see the internal components of the cassette 542. The base544 has needle guides 574 within which respective needles 576 areplaced. The proximal end of each needle 576 is configured as a connectorend 576C which has a slot 578 to mate with the needle receivers 532 ofthe suturing device when the cassette 542 is installed in the device.The distal end of the needles 576 are pointed into a tip 576T which willbe able to penetrate a sewing cuff of a prosthetic replacement heartvalve and engage a ferrule held in the ferrule holders of the cassette.Each needle 576 also has a needle cuff relief 580 which will bediscussed later in more detail. Each needle 576 also has a latch feature582 configured to be engaged by latch ends 584 of a flexible latch 586inside the cassette 542. When the needles 576 are in the needle guides574 of the base 544, the flexible latch 586 with two latch ends 584 iscoupled at a distal end 586D of the flexible latch 586 to correspondingkey features 588 in the base 544. The needles 576 are positioned so thatthe latch ends 584 fall into the latch features 582 on the needles 576,thereby restraining the needles 576 from moving out of the cassette 542.The cover 546 is attached to seal everything up and also to helpconstrain the needles 576 and the flexible latch 586. As mentioned, thisdesign has the advantage of keeping the needles away from the operatingstaff and the patient to improve safety for all involved.

FIGS. 40A, 40B, 40C, 40D, 40E, and 40F are top, front, left, right,back, and bottom views of the cassette of FIG. 38A.

FIG. 41A is a perspective view of a surgical situation where a suture590 has been stitched into a tissue 592 and ferrules 594 on the ends ofthe suture 590 are ready to be placed into the cassette of FIG. 38A. Aswill be discussed later in this specification, the ferrules areconfigured to couple to needle tips. The ferrules may be coupled to thesuture ends using a variety of techniques, including, but not limited togluing, crimping, or a combination thereof. In particular, the cassette542 has guide funnels 596 leading into the ferrule holders 566 to makeit easier for operating staff to pull the ferrules 594 into the ferruleholders 566.

FIG. 41B illustrates the ferrules 594 of FIG. 41A having been installedinto the cassette 542 of FIG. 38A. FIG. 41B-1 is an enlarged view of thedistal end of the cassette 542 from FIG. 41B showing the ferrules 594installed in the ferrule holders 566 of the cassette 542. FIG. 42illustrates multiple cassettes 542 in a surgical situation where eachcassette 542 is coupled to ferrules (not visible in this view) on theends of a different, respective sutures 590 that have been stitched intoa patient. The suture ends leading to each cassette 542 are being heldby one or more suture organizers 598. Once a desired number of sutures590 have been placed into a patient, for example, for emplacement of areplacement heart valve, each cassette 542 can then be loaded into thesurgical suturing device (such as the device of FIG. 34) in preparationfor further stitching the suture 590 through a sewing cuff of thereplacement heart valve. FIG. 43 shows a partially exposed view of theback side of the cassette 542 of FIG. 38A to illustrate the connectorends 576C of the needles in the cassette 574 and how they are configuredto mate with the needle receivers 532 (on the distal end of the needledrivers) of the surgical suturing device 482.

FIG. 44A illustrates the cassette 542 of FIG. 38A ready to be loadedinto the cassette receiver 484 of the suturing device 482 of FIG. 34. Asshown in FIGS. 44A and 44B, the pivots 552 (only one of which is visiblein this view) of the cassette 542 are placed into alignment with pivotreceivers 534 in the cassette receiver 484. FIG. 44B-1 is an enlargedview of the cassette 542 and cassette receiver 484 of FIG. 44B. Thealignment of the pivots 552 with the pivot receivers 534 can be clearlyseen in this view. As shown in FIG. 44C in conjunction with FIG. 44B-1,the cassette 542 is then rotated down around the cassette pivots 552 sothat the alignment tabs 554 on the cassette 542 move into the alignmentslots 538 of the cassette receiver 484. As this occurs, the needlerelease 536 of the cassette receiver 484 pushes up into the release slot572 of the cassette 542, the connector ends 576C of the needles 576 arecoupled to the needle receivers 532 of the suturing device 482, and theretention latches 558 of the flexible arms 556 on the cassette 542engage the retention features 540 of the cassette receiver 484 so thatthe cassette 542 is held firmly in place.

FIG. 45 is a partial cross-sectional view of the cassette 542 installedin the cassette receiver 484 of the suturing device. When the needlerelease 536 passes up through the release slot 572, it deflects theflexible latch 586 upwards, causing the latch ends 584 to move out ofthe latch features in the needles (not shown in this view). The needlesare held by the needle drivers, but they are now free to move if theneedle drivers are moved.

FIGS. 46A-46G are partially exposed views illustrating how the surgicalsuturing device 482, with its installed cassette 542, may be used toplace a suture stitch in a sewing cuff 600 of a replacement heart valve602. In FIG. 46A, a replacement heart valve 602 having a sewing cuff 600is shown. A cassette 542 is loaded into the suturing device 482. Thecassette 542 has two ferrules 594 loaded into the cassette's ferruleholders, and the ferrules 594 are each attached to the ends of the samesuture 590. The suture 590 has already been stitched through tissue, forexample an aortic root adjacent to where the replacement heart valvewill eventually be installed. The sewing cuff 600 is positioned belowthe cuff receiver 570, and then, as illustrated in FIG. 46B, the sewingcuff 600 is positioned within the cuff receiver 570. As shown in FIG.46C, the handle 486 may be squeezed towards the grip 494, and this willcause the needle drivers 496 to move distally. In the view of FIG. 46C,the handle 486 has not been illustrated as pivoted so that the motionarrow 604 can indicate its path of travel. However, the needle drivers496 are assumed to have moved the needles 576. This drives the needles576 out of the cassette 542, through the sewing cuff 600, and intocontact with the ferrules 594. This can better be seen in the enlargedview of FIG. 46C-1. The sewing cuff material 600 is stretched in adistal direction when the needles 576 pass through it. The needles 576in this embodiment, however, have a needle cuff relief 580 which allowsthe sewing cuff 600 to straighten back out before the needles 576 arefully retracted, thereby decreasing the likelihood of the needles 576jamming in the sewing cuff 600. Some embodiments may not have a needlecuff relief 580. As shown in FIG. 46D, the handle 486 can be released,causing the needle drivers 496 to retract the needles 576 back into thecassette 542. Since the needles 576 are now coupled to the ferrules 594,this pulls the ferrules 594 and suture 590 back through the sewing cuff600. This can be seen more clearly in the enlarged view of FIG. 46D-1.As shown in FIG. 46E, the replacement valve 602 can be removed from thecuff receiver 570 with the suture 590 stitched through it. As shown inthe enlarged view of FIG. 46E-1, the needles 576 and ferrules 594 arekept protected within the cassette 542. As shown in FIG. 46F, theflexible arms 556 of the cassette 542 may be pinched in to disengage theretention latches of the cassette from the retention features of thecassette receiver. This, then, allows the cassette 542 to be pivoted upon the pivots as shown in FIG. 46G and then removed from the cassettereceiver 484. This can be repeated as needed with other cassettes 542until all of the sutures have been placed through the sewing cuff 600 ofthe replacement valve 602 as illustrated in the surgical situation ofFIG. 47. The cassettes 542 still hold the ferrules on the suture ends,and the needles remain out of reach in each cassette 542. The sutures590 may be cut to sever the cassettes 542 from the suture ends asneeded. The cassettes 542 can also assist with suture management bykeeping the pairs of suture ends together and separate from other sutureends until needed.

FIG. 48 illustrates one embodiment of a magazine 604 having multiplecassettes 542. This embodiment combines the concepts of the magazineused earlier with the concept of the cassette more recently discussed.

FIG. 49A illustrates another embodiment of a surgical suturing device606 having a cassette receiver 484. This embodiment is similar to theembodiment of FIG. 34A, except that the needle drivers 608 (more visiblein the exposed view of FIG. 49B and the exploded view of FIG. 50) areall one piece and the needle receivers 610 on the needle drivers 608have a different shape. FIG. 51 is an enlarged view of a portion of theneedle drivers 608 in an exposed view of a portion of the surgicalsuturing device of FIG. 49A. FIG. 52 is an enlarged view of the needlereceivers 610 and the cassette receiver 484 of the surgical suturingdevice 606 of FIG. 49A. In this embodiment, the needle receivers 610 areshaped to receive a ball connector from a needle in a cassette. Whileneedle drivers 608 are shown in this embodiment, it should be noted thata singular or otherwise configured generic driver may also beimplemented for the purpose of actuating other modular apparatusincorporating surgical implements such as blades, scalpels or othersurgical instruments or implements may also be used in such a device.

FIGS. 53A and 53B are different perspective views of another cassette612 embodiment for use with the surgical suturing device of FIG. 49A.This cassette 612 is similar to the cassette of FIGS. 38A and 38B, buthas slightly different latching between the cover and the base, hasslightly differently shaped pivots 614, has different needles (notvisible in this view), and includes a loading alignment guide 616 on thedistal end of the cassette 612. The loading alignment guide 616 will bediscussed in more detail later in this specification.

FIG. 54 is an exploded view of the cassette of FIG. 53A. As noted above,the latching in this cassette is slightly different than the previouscassette. The previous cassette included latches which flexed andsnapped into place. This cassette has latches which pass from the base544 through the cover 546 and then require the base 544 and cover 546 toslide relative to each other in order to secure the latches in place. Asnoted previously, a wide variety of other techniques known to thoseskilled in the art exist for coupling the cover to the base. The needles618 are different, too, in FIG. 54. This embodiment does not have aneedle cuff relief, and the connector ends 618C are ball-shaped to fitthe different needle receivers 610 of the suturing device embodiment ofFIGS. 49 and 52.

FIGS. 55A, 55B, 55C, 55D, 55E, and 55F are top, front, left, right,back, and bottom views of the cassette of FIG. 53A.

FIG. 56A is a perspective view of a surgical situation where a suture590 has been stitched into a tissue 592 and ferrules 594 on the ends ofthe suture 590 are ready to be placed into the cassette 612 of FIG. 53A.FIG. 56B illustrates the ferrules 594 of FIG. 56A having been installedinto the cassette 612 of FIG. 53A. The description of these FIGS. issimilar to that of FIGS. 41A and 41B. FIG. 57 is an enlarged view of thedistal end of the cassette from FIG. 56B showing the ferrules 594installed in the cassette.

FIGS. 58A-58E illustrate how a suturing device 620 for placing stitchesin tissue may be coupled to the cassette 612 in order to facilitateloading of the ferrules 594 into the cassette 612. As shown in FIG. 58A,the tissue suturing device 620 has a tissue bite area 622. As known tothose skilled in the art, tissue may be positioned in the tissue bitearea 622 and then a tissue needle 624 may be extended from the positionshown in FIG. 58A, through the tissue in the tissue bite area 622, andinto contact with one or more ferrules 594 which are held incorresponding one or more ferrule holders 626 for the tissue suturingdevice 620. The tissue needle 624 can then be withdrawn back through thetissue to the position shown in FIG. 58A with the ferrules 594 attachedas shown in FIG. 58A. The tissue suturing device 620 can be removed fromthe tissue and the suture end(s) 628 coupled to the ferrules 594 will bepulled away from the tissue, too. For example, the tissue suturingdevice 620 could be used to place a stitch into an aortic root and thenthe device could be pulled out of a minimally invasive opening throughwhich it had been placed to make the stitch. The tissue suturing device620 also has the ability to move the needle 624 so that the ferrule 594is pushed against a ferrule removal device 630 which will push theferrule 594 off of the needle 624. In some embodiments, an operator mayuse this ferrule release feature 630 to release the ferrule 594 and thenthe ferrule 594 may be loaded by hand into the ferrule holder 566 of thecassette 612. In this embodiment, however, the cassette 612 has acassette nose 632 which is shaped to fit into the tissue bite area 622of the tissue suturing device 620 as illustrated in FIG. 58B. Theloading alignment guide 616 mates with a corresponding feature on thetissue suturing device 620 to ensure the ferrule 594 and suture 590coupled to the tissue needle 624 are in alignment with the ferruleholder 566 of the cassette 612. Depending on the embodiment, the ferruleand/or suture may be partially in the funnel opening leading to thecassette ferrule holder 566 while the ferrule is still attached to thetissue needle. When the ferrule removal feature 630 on the tissuesuturing device 620 is activated, as shown in FIG. 58C, the ferrule 594is released from the tissue needle 624. Now, an operator may pulldistally on the suture 590 to seat the ferrule 594 in the cassetteferrule holder 566 as shown in FIG. 58D. Finally, as illustrated in FIG.58E, the cassette 612 with the loaded ferrule 594 (or ferrules 594) maybe removed from the tissue suturing device 620. This may be an easierand quicker way to load the ferrules 594 into the cassette 612 and italso has the advantage of keeping the ferrules 594 aligned by notproviding an opportunity for the ferrules 594 to be mistakenly placed inan incorrect ferrule holder 566 (which could cause unwanted tangling ofsuture lines).

FIG. 58F is similar to FIG. 43, but showing the cassette 612 andcassette receiver 484 of FIGS. 53A and 52, respectively. It should benoted that a cassette or cassette receiver may include needles asheretofore described, or alternatively include another surgicalimplement such as a blade, scalpel or other implement.

FIGS. 59A and 59B are top and bottom perspective views, respectively, ofone embodiment of a modular incision apparatus 730. The modular incisionapparatus 730 houses a cutting blade 732 within a base 734 and a cover736 which are coupled together. It is one advantage of this system thatthe cutting blade 732 is kept inside the modular incision apparatus 730because it reduces the opportunity for the surgical staff and surgeon tobe cut during an operation by an exposed blade. By necessity, patientsare treated as though their blood carries harmful pathogens, so it isalways disconcerting when someone on a surgical team is cut or poked bya blade. By keeping the blade within the modular incision apparatus 730,away from skin, surgical procedures involving the apparatus 730 can besafer. There are a variety of ways the base 734 and cover 736 can becoupled together, including, but not limited to by latching, by gluing,and by welding. The modular incision apparatus 730 has multiple pivots738 (one of which is fully visible in FIGS. 59A, 59B, but the other issymmetrically located on the opposite side). The modular incisionapparatus 730 also has an alignment tab 740 on each side of theapparatus 730. The cover 736 has two flexible arms 742 which may bepinched inwardly. Each of the flexible arms 742 has a retention latch744 (one of which is visible in FIGS. 59A, 59B, but the other issymmetrically located on the other flexible arm). The base 734 has twoproximal openings 746 where the proximal end of the cutting blade (notshown) is accessible. In other embodiments, the two proximal openings746 may be combined into one shared proximal opening. The base 734 alsohas a distal opening 748 from which the distal end of the cutting blade732 exits. In other embodiments, the cover 736 or the base 734 and thecover 736 may be configured to define the distal opening 748 from whichthe cutting blade 732 exits. In this embodiment, the cover 736 defines ablade access notch 750 which allows the cutting blade 732 to be viewedand cleaned by rinsing with water if necessary, while still preventing auser from contacting the cutting edge 752 of the cutting blade 732 dueto the proximity of the blade's cutting edge 752 of the to the cover736. The base 734 also defines a release slot 754 which is sized toallow access to a flexible latch which acts as a cutting blade releasemechanism (not visible in this view) which normally keeps the cuttingblade 732 in the retracted position of FIGS. 59A and 59B. The use of atransparent material, such as glass, ceramic, or plastic may providevisual access to the blade or other internal components of the modularincision apparatus.

FIGS. 60A, 60B, 60C, 60D, 60E, and 60F are front, left, right, rear,top, and bottom elevational views, respectively, of the modular incisionapparatus of FIGS. 59A and 59B.

FIG. 61 is an exploded view of the modular incision apparatus of FIG.59A. The cutting blade 732 has two slides 756 which extend to theblade's proximal end 732P which is configured as a connector end. Eachof the slides 756 has a connector end 758 having a substantiallycircular shape at the proximal end 732P which are configured to matewith needle receivers on a suturing device when the modular incisionapparatus 730 is installed in the automated suturing device instead of aneedle cassette. In other embodiments, the coupling connector ends 758may have other shapes. The distal end 7360D of the cutting blade 732 hasthe sharp edge which is capable of cutting tissue. Each slide 756 of thecutting blade 732 also has a latch feature 760 configured to be engagedby latch ends 762 of a flexible latch 764 inside the modular incisionapparatus 730. When the slides 756 of the blade 732 are in the slideguides 766 of the base 734, the flexible latch 764 with two latch ends762 is coupled at a distal end 764D of the flexible latch 764 tocorresponding key features 768 in the base 734. The cutting blade slides756 are positioned so that the latch ends 762 fall into the latchfeatures 760 on the slides 756, thereby restraining the cutting blade732 from moving out of the modular incision apparatus 730. The cover 736is attached to seal everything up and also to help constrain the cuttingblade slides 756 and the flexible latch 764. As mentioned, this designhas the advantage of keeping the cutting blade away from the operatingstaff and the patient to improve safety for all involved.

FIG. 62 illustrates one embodiment of an automated suturing device 770,similar to the SEWEASY® Device from LSI Solutions, Inc. of Victor, N.Y.(www.lsisolutions.com). Such suturing devices 770 have a receiver 772for use with interchangeable suturing cassettes (not shown). A user ofthe automated suturing device 770 would hold the handle 774 and squeezethe lever 776 when it is desired to suture. Squeezing the lever 776towards the handle 774 advances a pair of needle drivers 778 in a distaldirection 780 using mechanisms known to those skilled in the art.

The modular incision apparatus 730 is designed to interface with anautomated suturing device 770 and take advantage of the motion of itsneedle drivers 778, thereby providing a safe and effective incisionapparatus at a very low cost by not needing to provide a separateactuation mechanism. FIG. 63 is a partially exposed perspective view ofthe modular incision apparatus 730 illustrating the features which willcouple with the automated suturing device 770. The pivots 738 (only oneof which is visible in this view) of the modular incision apparatus 730are placed into alignment with pivot receivers 782 in the receiver 772.The modular incision apparatus 730 can then be rotated down around thepivots 738 so that the alignment tabs 740 (only one of which is visiblein this view) on the modular incision apparatus 730 move into alignmentslots 784 of the receiver 772. As this occurs a release feature 786 ofthe receiver 772 pushes up into the release slot 754 (not visible inthis view, but discussed previously) of the modular incision apparatus730 to deflect the flexible latch 764 upwards, causing the latch ends762 to move out of the latch features 760 in the blade slides 756. Asthe modular incision apparatus 730 is rotated down around the pivots738, the connector ends 758 of the slides 756 are also coupled to needlereceivers 788 on the needle drivers 778, and the retention latches 744of the flexible arms 742 on the modular incision apparatus 730 engageretention features 790 of the receiver 772 so that the modular incisionapparatus 730 is held firmly in place.

FIGS. 64A and 64B are side cross-sectional views of the modular incisionapparatus 730 showing the cutting blade 732 in a retracted position andin an extended position, respectively. For simplicity, an actuator likethe automated suturing device 770 discussed previously is not shown inthis view. However, from the previous discussion, it should beunderstood how the connector ends 758 of proximal end 732P of the blade732 may be coupled to and driven forward to the position shown in FIG.64B by squeezing an actuation lever 776 (or a similar device known tothose skilled in the art). The blade 732 may also be retracted to theposition of FIG. 64A by releasing the actuation lever 776 (or a similardevice known to those skilled in the art). In use, the distal tip 792 ofthe modular incision apparatus 730 may be placed against a patient'sskin where a small incision is desired. The blade 732 may then beextended as shown in FIG. 64B and then retracted back to the position ofFIG. 64A. As noted previously, this has the advantage of only exposingthe blade when it is needed so that the risk of cuts to the surgicalstaff is greatly reduced. This also has the advantage of creating anincision which has a known depth that can be predetermined as part ofthe cassette design. In the example of FIGS. 64A and 64B, the blade 732travels a distance D₁ which is determined by the automated suturingdevice in which the modular incision apparatus will be installed.However, the blade 732 only extends a distance D₂ beyond the distal tip792 of the modular incision apparatus 730. Distance D₂ is the maximumincision depth that can be made when the blade 732 of the modularincision device 730 is extended. Distance D₂ is shorter than distance D₁in this embodiment, and the length L₁ from the end of the cutting blade732 to the distal tip 792 can be configured to create a desired maximumtravel distance, or maximum incision depth D₂, since: L₁=D₁−D₂, where:

L₁ is the length from the end of the cutting blade 732 to the distal tip792 when the cutting blade 732 is in the retracted position of FIG. 64A;D₁ is the distance the automated suturing device in which the modularincision apparatus 730 will be placed will move the blade 732; andD₂ is the desired maximum incision depth.Furthermore, this embodiment has the advantage of the access notch 750whereby the blade 732 may be inspected and cleaned if desired. Theaccess notch 750 may also provide pathways for the blade 732 to besterilized more easily.

FIGS. 65A and 65B are top and bottom perspective views, respectively, ofanother embodiment of a modular incision apparatus 794. This embodimentis similar to the previous embodiments, except that it does not have anaccess notch 750. This may be useful in situations where absolutely noaccess to the blade (not visible in this view) is desired until theblade is extended. Like the previous embodiments, the modular incisionapparatus 794 houses the cutting blade within a base 796 and a cover 798which are coupled together. There are a variety of ways the base 796 andcover 798 can be coupled together, including, but not limited to bylatching, by gluing, and by welding. The modular incision apparatus 794has multiple pivots 738 (one of which is fully visible in FIGS. 65A,65B, but the other is symmetrically located on the opposite side). Themodular incision apparatus 794 also has an alignment tab 740 on eachside of the apparatus 794. The cover 798 has two flexible arms 742 whichmay be pinched inwardly. Each of the flexible arms 742 has a retentionlatch 744 (one of which is visible in FIGS. 65A, 65B, but the other issymmetrically located on the other flexible arm). The base 796 has twoproximal openings 746 where the proximal end of the cutting blade (notshown) is accessible. In other embodiments, the two proximal openings746 may be combined into one shared proximal opening. The base 796 andthe cover 798 work together to define a distal opening 800 from whichthe distal end of the cutting blade 732 exits. The base 796 also definesa release slot 754 which is sized to allow access to a flexible latchwhich acts as a cutting blade release mechanism (not visible in thisview) which normally keeps the cutting blade 732 in the retractedposition of FIGS. 65A and 65B.

FIGS. 66A and 66B are side cross-sectional views of the modular incisionapparatus 794 showing the cutting blade 732 in a retracted position andin an extended position, respectively. For simplicity, an actuator likethe automated suturing device 770 discussed previously is not shown inthis view. However, from the previous discussion, it should beunderstood how the connector ends 758 of proximal end 732P of the blade732 may be coupled to and driven forward to the position shown in FIG.66B by squeezing an actuation lever 776 (or a similar device known tothose skilled in the art). The blade 732 may also be retracted to theposition of FIG. 66A by releasing the actuation lever 776 (or a similardevice known to those skilled in the art). In use, the distal tip 802 ofthe modular incision apparatus 794 may be placed against a patient'sskin where a small incision is desired. The blade 732 may then beextended as shown in FIG. 66B and then retracted back to the position ofFIG. 66A. As noted previously, this has the advantages of creating arepeatable incision depth and only exposing the blade when it is neededso that the risk of cuts to the surgical staff is greatly reduced.

Various advantages of a prosthetic suturing device have been discussedabove. Embodiments discussed herein have been described by way ofexample in this specification. Various advantages of a surgical suturingdevice with indexer and magazine, methods, and systems thereof have alsobeen discussed above. It will be apparent to those skilled in the artthat the forgoing detailed disclosure is intended to be presented by wayof example only, and is not limiting. Various alterations, improvements,and modifications will occur and are intended to those skilled in theart, though not expressly stated herein. These alterations,improvements, and modifications are intended to be suggested hereby, andare within the spirit and the scope of the claimed invention.Additionally, the recited order of processing elements or sequences, orthe use of numbers, letters, or other designations therefore, is notintended to limit the claims to any order, except as may be specified inthe claims. Accordingly, the invention is limited only by the followingclaims and equivalents thereto.

What is claimed is:
 1. A modular incision apparatus, comprising: a basehaving: a pair of pivots; a pair of alignment tabs; a proximal opening;and at least one slide guide; a cover coupled to the base, the coverhaving at least one retention latch; and a blade having: at least oneslide for movement within the at least one slide guide; a cutting edgeon a distal end; and a coupling connector on a proximal end which isaccessible via the proximal opening of the base.
 2. The modular incisionapparatus of claim 1, wherein the base further comprises a release slot.3. The modular incision apparatus of claim 1, further comprising aflexible latch held by one or more of the base and cover with one ormore latch ends configured to engage a latch feature on the blade. 4.The modular incision apparatus of claim 1, further comprising an accessnotch to provide visual and cleaning access to the blade.
 5. The modularincision apparatus of claim 4, wherein the access notch is defined bythe cover.
 6. The modular incision apparatus of claim 1, wherein atleast one of the cover and the base comprises a transparent material. 7.The modular incision apparatus of claim 1, wherein the couplingconnector comprises a substantially circular shape.
 8. The modularincision apparatus of claim 1, wherein the base, the cover, or bothdefine a distal opening from which the cutting edge may exit.
 9. Themodular incision apparatus of claim 1, wherein a maximum distance whichthe cutting edge of the blade may extend past a distal end of themodular incision apparatus is less than a maximum distance which theblade travels when moving the cutting edge to the maximum distance. 10.A modular surgical apparatus comprising: a base having: a pair ofpivots; a pair of alignment tabs; a proximal opening; and at least oneretention latch; a cover coupled to the base, the cover: having at leastone retention latch; and a surgical implement having a couplingconnector on a proximal end which accessible via the proximal opening ofthe base.